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FDA 510(k)

AMSafe 藥物輸注套件 (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

K 號：K252543 · 2026-05-04

申請人Amsino International, Inc.
決定日期2026-05-04
產品代碼FPA
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K252543. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)?

AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Amsino International, Inc.. The 510(k) number is K252543.

When did AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) receive FDA 510(k) clearance?

AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) received FDA 510(k) clearance on 2026-05-04, under 510(k) number K252543.

Who is the listed applicant for AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)?

The FDA 510(k) record lists Amsino International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)?

The FDA product code for AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) is FPA.

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相關器械（代碼：FPA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254123Ecomed 一次性注射用藥物輸注套件Ecomed Solutions, LLCK261530iiSure 靜脈輸注套件Deka Research and DevelopmentK251375PuraCath 火飛無針連接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定組 [6426733]; nSet+ 稳定組搭配 nSyte 非針刺連接器 (NFC) [6426731]; nSyte 非針刺連接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵輸注套件Carefusion (Bd)K251814EZ™ 靜脈注射輸液套組Epic Medical Pte. , Ltd.

官方來源

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